1. Field of the Invention
The present invention relates generally to the field of sphincterotomy. More particularly, the present invention relates to the field of medical devices such as sphincterotomes/papillotomes to provide controlled bending and orienting during cutting of the patient's sphincter.
2. Description of the Prior Art
In endoscopic sphincterotomy, sphincterotomes and more specifically papillotomes, are used in conjunction with an endoscope to provide surgical cutting inside of a patient. The sphincterotome/papillotome may be used to partially cut open the sphincter muscle for treatment such as removal of common bile duct stones forming an obstruction. The prior art sphincterotomes/papillotomes include the blade cutting wire for cutting the sphincter muscle. The disadvantage with prior art sphincterotome/papillotome is that when it is fished through the body and the cutting wire comes in contact with the sphincter muscle, the precise angle at which the cutting wire is located relative to the sphincter muscle cannot be accurately controlled and it is a hit or miss procedure. The angle of the cutting wire must be exactly twelve o'clock position in order to properly cut the sphincter muscle.
The following eleven (11) prior art patents are found to be pertinent to the field of the present invention:
1. U.S. Pat. No. 2,843,128 issued to Storz on Jul. 15, 1958 for "Adenotome" (hereafter the "Storz Patent"); PA1 2. U.S. Pat. No. 4,811,735 issued to Nash et al. on Mar. 14, 1989 for "Stone Destroying Catheter And Method Of Use" (hereafter the "Nash Patent"); PA1 3. U.S. Pat. No. 5,024,617 issued to Karpiel on Jun. 18, 1991 for "Sphincterotomy Method And Device Having Controlled Bending And Orientation" (hereafter the "Karpiel Patent"); PA1 4. U.S. Pat. No. 5,026,371 issued to Rydell et al. on Jun. 25, 1991 for "Handle For Polypectome Snare With Bipolar Electrodes " (hereafter the "'371 Rydell Patent"); PA1 5. U.S. Pat. No. 5,053,044 issued to Mueller et al. on Oct. 1, 1991 for "Catheter And Method For Making Intravascular Incisions" (hereafter the "Mueller Patent"); PA1 6. U.S. Pat. No. 5,071,424 issued to Reger on Dec. 10, 1991 for "Catheter Atherotome" (hereafter the "Reger Patent"); PA1 7. U.S. Pat. No. 5,092,872 issued to Segalowitz on Mar. 3, 1992 for "Valvulotome Catheter" (hereafter the "Segalowitz Patent"); PA1 8. U.S. Pat. No. 5,152,772 issued to Sewell, Jr. on Oct. 6, 1992 for "Sphincterotomy Catheter And Method" (hereafter the "Sewell Patent"); PA1 9. U.S. Pat. No. 5,163,942 issued to Rydell on Nov. 17, 1992 for "Surgical Instrument With Grasping Loop For Laparoscopic Procedures" (hereafter the "'942 Rydell Patent"); PA1 10. U.S. Pat. No. 5,241,970 issued to Johlin, Jr. et al. on Sep. 7, 1993 for "Papillotome/Sphincterotome Procedures And A Wire Guide Specially Suited Therefor" (hereafter the "Johlin Patent"); and PA1 11. U.S. Pat. No. 5,423,844 issued to Miller on Jun. 13, 1995 for "Rotary Surgical Cutting Instrument" (hereafter the "Miller Patent").
The Storz Patent discloses an adenotome. It comprises a body with a bar slidable in the body. A pair of finger-receiving rings are fixed to the left hand end of the body and a thumb receiving ring swivels on the corresponding end of the bar.
The Nash Patent discloses a stone destroying catheter and method of use. It comprises a small diameter catheter with a longitudinal axis and a working head located at the distal end. The catheter is capable of being located at any position within the body so that the working head is adjacent the stone. The working head is rotated at high speed about the longitudinal axis of the catheter.
The Karpiel Patent discloses a sphincterotomy method and device having controlled bending and orientation. It comprises a multi-lumen tubular member, with one lumen having an electrical conductor, and the other lumen having a reinforcing wire. The reinforcing wire has a rectangular cross-section, providing a greater moment of inertia in a resisting axis than in a bending axis.
The '371 Rydell Patent discloses a handle for polypectome snare with bipolar electrodes.
The Mueller Patent discloses a catheter and method for making intravascular incisions. The vascular catheter includes a blade tip at its distal end. The blade is mounted within the blade tip and a mechanism is provided for extending the blade transversely when the blade tip is located within a region of stenosis.
The Reger Patent discloses a catheter atherotome.
The Segalowitz Patent discloses a valvulotome catheter. It is used for cutting the bi-cuspid venous valves free from the wall of a vein to be used in bypass vein graft surgery. The end portion is rotatably supported from a tube by way of a shaft. The shaft terminates at its distal end in a blade support member which carries the longitudinally fixed cutting blades. Rotation of the shaft enhances the cutting of the catheter.
The Sewell Patent discloses a sphincterotomy catheter and method. It comprises an elongated longitudinal channel, two separate balloons located at the distal end of the catheter, and a cutting means extendable from the catheter between the balloons. The first balloon is inflated by introducing a gas or a fluid to a first port which flows through the first lumen into the first balloon. Similarly, the second balloon is inflated by introducing a gas or a fluid to a second port which flows through the second lumen and into the second balloon.
The '942 Rydell Patent discloses a surgical instrument with a grasping loop for laparoscopic procedures. It comprises a knob which is rotatable and causes a pinion gear to be turned clockwise, engaging both racks. The rack will be moved toward a proximal end as the rack moves toward a distal end of the handle, thus effectively rotating the grasping loop and any tissue held therein.
The Johlin Patent discloses papillotome/sphincterotome procedures and a wire guide specially suited therefor. The wire guide comprises an outer insulative tube, an inner shaft and a platinum coil at its distal end. The outer tube loosely accommodates the inner shaft with a cushion of air therebetween for additional insulative effect, and the platinum alloy coil is also loosely positioned within the outer tubing.
The Miller Patent discloses a rotary surgical cutting instrument which is used for cutting tissue within an anatomical space. It comprises an outer cannula for percutaneous insertion into the anatomical space. The outer cannula has a central bore along its length and a cutting opening adjacent the distal end sized to receive tissue therethrough. A rotatably driven tubular cutting member is disposed within the central bore of the outer cannula, with a cutting edge rotating beneath the cutting opening of the cannula
It is highly desirable to have a very efficient and also very effective design and construction of a rotatable sphincterotome/papillotome device to enhance the control which a physician has in performing a sphincterotomy, and provides a reduced risk of inadvertent or uncontrolled cuts which may injure the patient. It is also desirable to provide an improved device with the capability of orienting the angle of the cutting wire to the exact cutting position (between 11 o'clock to 1 o'clock) when the device exits the endoscope for cutting the sphincter muscle. It is further desirable to provide an improved device which overcomes the limitations of other devices and provides for a controlled, and safer cutting of the sphincter muscle. Furthermore, the device does not have to exit the endoscope in the correct orientation, because through visualizing the angle with the endoscope and through the ratchet rotating mechanism, the angle of the cutting wire can be rotated to the exact cutting position at all times before the sphincter muscle is cut. Accordingly, the physician maintains a greater control during endoscopic sphincterotomy, and reduces the risk of improper cuts and the associated complications.